BRIMONIDINE TARTRATE 0.25% / IVERMECTIN 1% / METRONIDAZOLE 1% / NIACINAMIDE 4%- brimonidine tartrate 0.25% / ivermectin 1% / metronidazole 1% / niacinamide 4% gel 
Sincerus Florida, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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BRIMONIDINE TARTRATE 0.25% / IVERMECTIN 1% / METRONIDAZOLE 1% / NIACINAMIDE 4%

Directions for use

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Sincerus Florida, LLC. Adverse reactions

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Active, inactive

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NDC 72934- 1028-2 BRIMONIDINE TARTRATE USP 0.25% / IVERMECTIN USP 1% / METRONIDAZOLE USP 1% / NIACINAMIDE USP 4%

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BRIMONIDINE TARTRATE 0.25% / IVERMECTIN 1% / METRONIDAZOLE 1% / NIACINAMIDE 4% 
brimonidine tartrate 0.25% / ivermectin 1% / metronidazole 1% / niacinamide 4% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE) BRIMONIDINE TARTRATE0.25 g  in 100 g
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E) METRONIDAZOLE1 g  in 100 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE4 g  in 100 g
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) IVERMECTIN1 g  in 100 g
Product Characteristics
Coloryellow (OFF WHITE GEL) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-1028-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/16/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-1028)

Revised: 5/2019
Document Id: 88f00580-a0ca-168f-e053-2a95a90a6e4b
Set id: 88f00580-a0c9-168f-e053-2a95a90a6e4b
Version: 1
Effective Time: 20190515
 
Sincerus Florida, LLC